INTRODUCTION

The Cardiac Troponin I (cTnI) Rapid Test Kit is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of cardiac tropnin I (cTnI) and its complex in human whole blood, serum or plasma specimens at a level of 1.0 ng/mL or greater. It is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of health care providers.

INTENDED USE

Cardiac Troponin I (cTnI) is a cardiac muscle protein with a molecular weight of 22.5 kilodalton.1 Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.2 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity often measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma.3 cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery.4 Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.5 The Troponin I Rapid Test is a simple rapid test which utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in human whole blood, serum or plasma specimens at the cut-off level of 1.0 ng/mL